Treatment patterns and outcomes in secondary acute myeloid leukemia arising after hypomethylating agents: PETHEMA registry study.

Background: Patients with secondary acute myeloid leukemia who previously received hypomethylating agents for prior myeloid neoplasms (HMA-sAML) face a dismal prognosis.

Methods: The authors analyze the characteristics, therapeutic approaches, and outcomes of patients with HMA-sAML from the Programa Español para el Tratamiento de Hemopatías Malignas (PETHEMA) registry.

Results: A total of 479 patients were included, mostly from prior myelodysplastic syndrome (84%).

[Translated article] National registry and analysis of pharmaceutical interventions in critical care units: PHARMACRITIC study.

Objective: To design a homogeneous methodology for the registration and analysis of pharmaceutical interventions performed in spanish intensive adults care units (ICUs).

Method: Observational, prospective, and multicentre study. In the first stage, a national registry of pharmaceutical interventions will be agreed upon and subsequently, all the pharmaceutical interventions performed on adult patients admitted to Spanish ICUs during 8 weeks will be recorded.

Analysis of the situation of pharmaceutical care for patients with immune-mediated inflammatory diseases before and after the COVID-19 pandemic.

Objective: To describe, analyse, and compare the situation of pharmaceutical care consultations for outpatients with immune-mediated inflammatory diseases of the Pharmacy Services of Spain at 2 different times.

Method: Longitudinal, multicentre, and unidisciplinary descriptive observational study, carried out by the Immune-mediated Inflammatory Diseases Working Group of the Spanish Society of Hospital Pharmacy through a virtual survey in 2019 and 2021. Variables were collected regarding coordination, resources, biosimilars, unmet needs, and telepharmacy.

Prospective observational follow-up study of psychoactive drugs treatment initiated in the intensive care unit.

Objective: The treatment and prevention of delirium in the intensive care unit (ICU) have gained significant importance in patient care in recent years. Some studies have linked delirium with increased risks of mortality, prolonged hospital stay, and more days of mechanical ventilation. This study aims to analyze the use of psychotropic drugs initiated in the ICU and their continuation upon hospital discharge, as well as to evaluate their contribution to polypharmacy and associated adverse clinical effects.

[Translated article] Knowledge of biological therapy in patients with immune-mediated diseases. BIOINFO study.

Objective: To determine the degree of knowledge about biological therapy and biosimilars in patients with immune-mediated inflammatory diseases treated in Outpatient Pharmaceutical Care Units.

Methods: Observational, prospective, and multicenter study during the period May 2020-March 2021. A survey (9 questions) was conducted before starting treatment in which the patients' level of knowledge about biological therapy and biosimilars was assessed.

Therapeutic Drug Monitoring of antibiotic and antifungical drugs in paediatric and newborn patients. Consensus Guidelines of the Spanish Society of Hospital Pharmacy (SEFH) and the Spanish Society of Paediatric Infectious Diseases (SEIP).

Therapeutic monitoring of antibiotics and antifungals based on pharmacokinetic and pharmacodynamic (PK/PD) parameters is a strategy increasingly used for the optimization of therapy to improve efficacy, reduce the occurrence of toxicities, and prevent the selection of antimicrobial resistance, particularly in vulnerable patients including neonates and the critical or immunocompromised paediatric host. In neonates and children, infections account for a high percentage of hospital admissions, and anti-infectives are the most used drugs. However, paediatric PK/PD studies and the evidence regarding the efficacy and safety of some newly marketed antibiotics and antifungals-usually used off-label in paediatrics-to determine the optimal drug dosage regimens are limited.

[Translated article] Therapeutic Drug Monitoring of antibiotic and antifungical drugs in paediatric and newborn patients. Consensus Guidelines of the Spanish Society of Hospital Pharmacy (SEFH) and the Spanish Society of Paediatric Infectious Diseases (SEIP).

Therapeutic monitoring of antibiotics and antifungals based on pharmacokinetic and pharmacodynamic (PK/PD) parameters is a strategy increasingly used for the optimization of therapy to improve efficacy, reduce the occurrence of toxicities, and prevent the selection of antimicrobial resistance, particularly in vulnerable patients including neonates and the critical or immunocompromised paediatric host. In neonates and children, infections account for a high percentage of hospital admissions, and anti-infectives are the most used drugs. However, paediatric PK/PD studies and the evidence regarding the efficacy and safety of some newly marketed antibiotics and antifungals-usually used off-label in paediatrics-to determine the optimal drug dosage regimens are limited.

Spanish Society of Hospital Pharmacy and the Spanish Society of Pediatric Infectious Diseases (SEFH-SEIP) National Consensus Guidelines for therapeutic drug monitoring of antibiotic and antifungal drugs in pediatric and newborn patients.

Therapeutic monitoring of antibiotics and antifungals based on pharmacokinetic and pharmacodynamic parameters, is a strategy increasingly used for the optimization of therapy to improve efficacy, reduce the occurrence of toxicities, and prevent the selection of antimicrobial resistance, particularly in vulnerable patients including neonates and the critical or immunocompromised host. In neonates and children, infections account for a high percentage of hospital admissions and anti-infectives are the most used drugs. However, pediatric pharmacokinetic and pharmacodynamic studies and the evidence regarding the efficacy and safety of some newly marketed antibiotics and antifungals -usually used off-label in pediatrics- to determine the optimal drug dosage regimens are limited.

[Translated article] New challenges in advanced therapies.

The huge development that advanced therapy medicinal products (AMTPs) have experienced in recent years, both commercial and research, represent a challenge for hospital pharmacy at all levels. The aim of this article is to describe the implementation of an advanced therapies unit (AUT) and the process of preparation of the AMTPs according to the "good manufacturing practices" (GMP), as well as the results obtained in a tertiary hospital, as an example of the challenges posed by MTA's academic production. The AUT meets the requirements established in the GMP by guaranteeing that the medicines produced therein are of the quality required for the use for which they are intended, and also provides support to various research groups involved in the development of AMTPs.

New challenges of advanced therapies.

The huge development that Advanced Therapy Medicinal Products (AMTPs) have experienced in recent years, both commercial and research, represent a challenge for Hospital Pharmacy at all levels. The aim of this article is to describe the implementation of an Advanced Therapies Unit (AUT) and the process of preparation of the AMTPs according to the "good manufacturing practices" (GMP), as well as the results obtained in a tertiary hospital, as an example of the challenges posed by MTA's academic production. The AUT meets the requirements established in the GMP by guaranteeing that the medicines produced therein are of the quality required for the use for which they are intended, and also provides support to various research groups involved in the development of AMTPs.

National record and analysis of pharmaceutical interventions in critical care units: PHARMACRITIC study.

Objective: To design a homogeneous methodology for the registration and analysis of pharmaceutical interventions performed in Spanish critical adults' care units.

Method: Observational, prospective and multicenter study. In the first stage, a national registry of pharmaceutical interventions will be agreed upon and subsequently all the pharmaceutical interventions performed on adult patients admitted to Spanish CCUs during eight weeks will be recorded.

Knowledge of biological therapy for patients with immune-mediated diseases. BIOINFO Study.

Objective: To determine the degree of knowledge about biological therapy and biosimilars in patients with immune-mediated inflammatory diseases treated in Outpatient Pharmaceutical Care Units.

Methods: Observational, prospective and multicenter study during the period May 2020-March 2021. A survey (9 questions) was conducted before starting treatment in which the patients' level of knowledge about biological therapy and biosimilars was assessed.

Therapeutic drug monitoring in inflammatory bowel diseases. Position statement of the Spanish Working Group on Crohn's Disease and Ulcerative Colitis.

The treatment of inflammatory bowel disease has undergone a significant transformation following the introduction of biologic drugs. Thanks to these drugs, treatment goals have evolved from clinical response and remission to more ambitious objectives, such as endoscopic or radiologic remission. However, even though biologics are highly effective, a significant percentage of patients will not achieve an initial response or may lose it over time.

[Translated article] Good humanisation practices in the healthcare of patients with rare diseases in Pharmacy Services.

Objective: To analyse the presence of Good Humanisation Practices in the care of patients with rare diseases in Hospital Pharmacy Services and to identify the strengths and prevalent areas for improvement in the humanisation of healthcare.

Methods: An online questionnaire structured in 2 parts was developed using Google Form®. The first one was designed to collect identifying data and the second one included questions related to compliance with the 61 standards of the Manual of Good Humanisation Practices in the healthcare of patients with rare diseases in Hospital Pharmacy Services.

[Translated article] Checklist for the pharmaceutical care of patients with interstitial lung disease (CheckEPID): A Delphi-based consensus.

Objective: To develop a checklist to facilitate pharmaceutical care for patients with interstitial lung disease who require or are undergoing treatment with antifibrotic drugs.

Method: Five hospital pharmacists developed an initial list of 37 items divided into 4 blocks: (1) First visit, which included general patient data and data from the first treatment; (2) follow-up visits, assessing aspects of the follow-up of the treatment with nintedanib or pirfenidone; (3) telepharmacy, consisting of the evaluation of the inclusion of patients in a program of this type, course of the disease, and identification of the contact with the pharmacy service; (4) non-pharmacological treatment and patient information. To decide its potential inclusion in the checklist, 2 rounds of the Delphi were carried out in which the panelists had to assess the degree of agreement of each proposed item according to its "utility", which was the determining criterion for its inclusion, and its "applicability".

Consensus statement on the use of biosimilar drugs in immune-mediated diseases in Spain.

Objective: To improve knowledge about biosimilar medicines and to generate a consensus framework on their use.

Methods: Qualitative study. A multidisciplinary group of experts in biosimilar medicines was established (1dermatologist, 1hospital pharmacist, 1rheumatologist, and 1gastroenterologist) who defined the sections and topics of the document.

Analysis of the degree of implementation of medication error prevention practices in Spanish hospitals (2022).

Objective: To assess the degree of implementation of medication error prevention practices in Spanish hospitals.

Method: Descriptive multicenter study of the degree of implementation of the safety practices included in the "Medication use-system safety self-assessment for hospitals. Version.

Checklist for Pharmaceutical Care of the Patient with interstitial lung disease (CheckEPID): A Delphi-based consensus.

Objective: To develop a checklist to facilitate pharmaceutical care for patients with interstitial lung disease who require or are undergoing treatment with antifibrotic drugs.

Method: Five hospital pharmacists developed an initial list of 37 items divided into 4 blocks: 1) First visit, which included general patient data and data from the first treatment; 2) Follow-up visits, assessing aspects of the follow-up of the treatment with nintedanib or pirfenidone; 3) Telepharmacy, consisting of the evaluation of the inclusion of patients in a program of this type, course of the disease, and identification of the contact with the pharmacy service; 4) Non-pharmacological treatment and patient information. To decide its potential inclusion in the checklist, two rounds of the Delphi were carried out in which the panelists had to assess the degree of agreement of each proposed item according to its "utility", which was the determining criterion for its inclusion, and its "applicability".

Pharmacist care in hospital emergency departments: a consensus paper from the Spanish hospital pharmacy and emergency medicine associations.

Objectives: To draft a list of actions and quality indicators for pharmacist care in hospital emergency departments, based on consensus among a panel of experts regarding which actions to prioritize in this setting.

Material And Methods: A panel of experts from the Spanish Society of Hospital Pharmacy (SEFH) and the Spanish Society of Emergency Medicine (SEMES) evaluated a preliminary list of potential actions and quality of care indicators. The experts used a questionnaire to assess the proposals on the basis of available evidence.

Extravasation of monoclonal antibodies commonly used in oncology: Classification, management and the role of the pharmacist.

Introduction: Extravasation by conventional cytotoxics has been well documented. While monoclonal antibodies are not considered to have the necrotic potential of some cytotoxic medicines, they require appropriate management in case of extravasation. However, fewer data are available on their classification and appropriate management when extravasation occurs.

Outcomes after intensive chemotherapy for secondary and myeloid-related changes acute myeloid leukemia patients aged 60 to 75 years old: a retrospective analysis from the PETHEMA registry.

Treatment options for patients with secondary acute myeloid leukemia (sAML) and AML with myeloid-related changes (AMLMRC) aged 60 to 75 years are scarce and unsuitable. A pivotal trial showed that CPX-351 improved complete remission with/without incomplete recovery (CR/CRi) and overall survival (OS) as compared with standard "3+7" regimens. We retrospectively analyze outcomes of 765 patients with sAML and AML-MRC aged 60 to 75 years treated with intensive chemotherapy, reported to the PETHEMA registry before CPX-351 became available.

GEDEFO-SEFH management of antineoplastic extravasations survey results.

Introduction: Extravasation is a potentially severe complication of intravenous administration of antineoplastic drugs. The limited data makes it difficult to develop an optimal management scheme. The objective of this study is to describe the clinical practice in the extravasation management of antineoplastic agents in Spanish centers.